StrokeCAVI-JNCT01859897
A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
An observational study of Stroke and Cardiovascular Death, run by CAVI-J Study Group at 1 site in Japan.
Trial summary
The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Stroke, Cardiovascular Death, Nonfatal Myocardial Infarction
- How many people
- 3,026 participants
- Where
- 1 siteJapan
- Study dates
- May 2013to Apr 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primiary care clinic and hospital
Who may be able to join
- Patients between 40 and 74 years of age who have either of the following:
- Type 2 diabetes mellitus
- Metabolic syndrome
- Grade I to III hypertension with the third layer of risk factors according to the guidelines for the management of hypertension japanese society of hypertension(JSH)2009
- Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
- History of coronary artery disease or noncardiogenic cerebral infarction
Who cannot join
- Under 40 years of age or over 74 years of age
- An ankle-brachial index less than 0.9
- Chronic atrial fibrillation
- Current symptoms of heart failure(NYHA class III or IV) or left ventricular dysfunction (EF below 40%)
- Malignancy
- Chronic kidney disease(G4 or G5)according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
Show all 9Show fewer
- chronic dialysis due to renal failure
- Taking steroids/immunosuppressants
- Hepatocirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.
- Conditions
- Stroke, Cardiovascular Death, Nonfatal Myocardial Infarction
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Optimal therapy | All subjects will be treated by optimal medical therapy and lifestyle modification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardiac events
cardiac death, nonfatal myocardial infarction, stroke
Measured: five years
Secondary outcomes (1)
all cause mortality, cardiovascular events, and renaly dysfunction
all cause death, angina pectoris (with revascularization), New incidence of lower limb peripheral arterial disease(including lower limb arteriosclerosis obliterans), Aortic aneurysm, Aortic dissection, Heart failure that requires hospitalization, Deterioration in renal function (dialysis or renal transplantation)
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,026 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- CAVI-J Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Toho University, Ehime University Graduate School of Medicine, Dokkyo Medical University, Okayama University
- Responsible party
- Sponsor-investigator, CAVI-J Study Group, Okayama University
- Investigators
- Hajime Orimo, MD, Principal investigator, Kenkoin Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859897
- Sponsor's protocol ID
- okayama-1692
- Acronym
- CAVI-J
- Status last verified
- Sep 2020
- First submitted
- 20 May 2013
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miyoshi T, Ito H, Shirai K, Horinaka S, Higaki J, Yamamura S, Saiki A, Takahashi M, Masaki M, Okura T, Kotani K, Kubozono T, Yoshioka R, Kihara H, Hasegawa K, Satoh-Asahara N, Orimo H; CAVI-J (Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan) investigators *. Predictive Value of the Cardio-Ankle Vascular Index for Cardiovascular Events in Patients at Cardiovascular Risk. J Am Heart Assoc. 2021 Aug 17;10(16):e020103. doi: 10.1161/JAHA.120.020103. Epub 2021 Aug 7.
PubMed 34369198
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
- ClinicalTrials.gov ID
- NCT01859897
- Acronym / sponsor ID
- CAVI-J / okayama-1692
- Conditions
- Stroke, Cardiovascular Death, Nonfatal Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,026 participants (actual)
- Lead sponsor
- CAVI-J Study GroupUniversity, hospital or other
- Collaborators
- Toho University, Ehime University Graduate School of Medicine, Dokkyo Medical University, Okayama University
- Study start
- May 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimal therapy | – | –All subjects will be treated by optimal medical therapy and lifestyle modification. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primiary care clinic and hospital
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Metabolic syndrome
- Grade I to III hypertension with the third layer of risk factors according to the guidelines for the management of hypertension japanese society of hypertension(JSH)2009
- Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
- History of coronary artery disease or noncardiogenic cerebral infarction
Key exclusion criteria (9 listed)
- Under 40 years of age or over 74 years of age
- An ankle-brachial index less than 0.9
- Chronic atrial fibrillation
- Current symptoms of heart failure(NYHA class III or IV) or left ventricular dysfunction (EF below 40%)
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major cardiac events
Time frame: five years
cardiac death, nonfatal myocardial infarction, stroke
1 secondary outcome
all cause mortality, cardiovascular events, and renaly dysfunction
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 34369198Miyoshi T, Ito H, Shirai K, Horinaka S, Higaki J, Yamamura S, Saiki A, Takahashi M, Masaki M, Okura T, Kotani K, Kubozono T, Yoshioka R, Kihara H, Hasegawa K, Satoh-Asahara N, Orimo H; CAVI-J (Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan) investigators *. Predictive Value of the Cardio-Ankle Vascular Index for Cardiovascular Events in Patients at Cardiovascular Risk. J Am Heart Assoc. 2021 Aug 17;10(16):e020103. doi: 10.1161/JAHA.120.020103. Epub 2021 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hajime Orimo, MD principal investigator
Kenkoin Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cardiovascular Death, run by CAVI-J Study Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major cardiac events (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.